Table 1.
Placebo (n = 363) | Teriflunomide 7 mg (n = 365) | Teriflunomide 14 mg (n = 358) | Relative change (%)a | |||
---|---|---|---|---|---|---|
7 mg vs. placebo | 14 mg vs. placebo | 7 mg vs. 14 mg | ||||
Patients free of relapses with sequelae-EDSS/FS [% (n), 30 days post onset of relapse]b | 64.7 (235) | 72.3 (264) | 77.4 (277) | 12 p = 0.0311 | 20 p = 0.0002 | p = 0.124 |
Patients free of relapses with sequelae-investigator [% (n), end of relapse]c | 77.4 (281) | 80.0 (292) | 86.9 (311) | 3 p = 0.42 | 12 p = 0.0009 | p = 0.016 |
Patients free of relapses leading to hospitalization [% (n)] | 80.4 (292) | 86.0 (314) | 90.8 (325) | 7 p = 0.047 | 13 p < 0.0001 | p = 0.049 |
Patients free of relapses requiring IV corticosteroids [% (n)]d | 55.1 (200) | 62.5 (228) | 66.5 (238) | 13 p = 0.050 | 21 p = 0.002 | p = 0.23 |
ITT intention to treat, IV intravenous, TEMSO TEriflunomide Multiple Sclerosis Oral
aRelative change: a positive number indicates more patients free from relapse compared with placebo
bIncomplete neurological recovery, defined by an increase in the Expanded Disability Status Scale (EDSS) or Functional system (FS) 30 days post relapse
cIncomplete neurological recovery, as assessed by the investigator at the end of relapse
dMissing data regarding intravenous (IV) corticosteroid use was reported in 12.6 % of relapses